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4. Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)

Author

Baos, Sarah, Todd, Rachel, Thirard, Russell, Harris, Rosie, Kirwan, Jana, Joyce, Katherine, Hutton, David, Finn, Adam, Clout, Madeleine, Cappel-Porter, Heike, Rogers, Chris A, Lazarus, Rajeka, and Culliford, Lucy

Published
2024
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6. Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial

Author

Baos, Sarah, Sheehan, Karen, Culliford, Lucy, Pike, Katie, Ellis, Lucy, Parry, Andrew J, Stoica, Serban, Ghorbel, Mohamed T, Caputo, Massimo, and Rogers, Chris A

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundDuring open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. ObjectiveThe Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. MethodsThis is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. ResultsA total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. ConclusionsWe believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. Trial RegistrationISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG).

Published
2015
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8. Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS)

Author

Angelini, Gianni D, primary, Reeves, Barnaby C, additional, Culliford, Lucy A, additional, Maishman, Rachel, additional, Rogers, Chris A, additional, Anastasiadis, Kyriakos, additional, Antonitsis, Polychronis, additional, Argiriadou, Helena, additional, Carrel, Thierry, additional, Keller, Dorothée, additional, Liebold, Andreas, additional, Ashkaniani, Fatma, additional, El-Essawi, Aschraf, additional, Breitenbach, Ingo, additional, Lloyd, Clinton, additional, Bennett, Mark, additional, Cale, Alex, additional, Gunaydin, Serdar, additional, Gunertem, Eren, additional, Oueida, Farouk, additional, Yassin, Ibrahim M, additional, Serrick, Cyril, additional, Murkin, John M, additional, Rao, Vivek, additional, Moscarelli, Marco, additional, Condello, Ignazzo, additional, Punjabi, Prakash, additional, Rajakaruna, Cha, additional, Deliopoulos, Apostolos, additional, Bone, Daniel, additional, Lansdown, William, additional, Moorjani, Narain, additional, and Dennis, Sarah, additional

Published
2024
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11. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial

Author

Adams, Kirsty, Alaee, Seema, Aley, Parvinder K., Allum, Emma, Anthony, Sally, Ashton, Kate, Awal, Tanya, Barnett, Liz, Barratt, Alison, Barron, Charlotte, Baum, Holly, Beard, Chloe, Bennett, Lorna, Bird, Samuel, Bishop, Sarah, Bisset, Jess, Bodalia, Pritesh, Bowles, Jane, Bowyer, Catherine, Bradburn, Kirstie, Bray, Jonathan J.H., Bressington, Catherine, Brimfield, Matthew, Broad, Lauren, Brown, Pauline, Brydon-Hill, Ruth, Burge, Sharon, Carmichael, David, Chohan, Gurjit, Clark, Tonia, Close, Adrianne, Coleman, Tom, Cowley, Claire, Cranfield, Charlotte, Cross, Eleanor, D'Agostino, Alyssa, D'Arcangelo, Silvia, David Otter, Ashley, Davies, Kate, Davies, Catrin, Davies, Ru, Davies, Louisa, Driver, Kimberley, Eglinton, Charlotte, Ekblad, Charlotte, Eldridge, Emma, Evans, Teriann, Evans, Mim, Evans, Isabel, F Mujadidi, Yama, Farrow, Amanda, Faulkner, Beverley, Feltham, Sally, Figueirido, Susan, Ford, Jamie, Foxwell, David, Frayling, Sharon, Gardiner, Sophie, Gooch, Karen E., Goodwin, Jayne, Halliday, Alice, Hamal, Shama, Harrhy, Sarah, Harris, Andrew, Haxton, Lesley, Haynes, Matthew, Hazell, Mae, Hembrough, Tracey, Hewson, Jacqueline, Hicks, Bethany, Higgins, Thomas, Hill, Michelle, Hills, Alex, Hilton, Zoe, Hitchings, Benjamin, Hua, Cheryl, Iftikhar, Hina, Iqbal, Attya, Jones, Laura, Jones, Nicola, Kellett Wright, Johanna, Kidd, Sarah, Kirby, Alison, Knibbs, Lucy, Lamb, Jenny, Langton, Helen, Leach, Rwth, Lewis-Clarke, Phoebe, Lloyd, Amy, Maclean, Kirsty, Manning, Nicola, Marriott, Anthony, McFadzean, Isobel Joy, McLaughlin, Maeve, McQueen, Alison, Mills, Bianca, Naik, Gurudutt, Nicholls, Lisa, Norman, Chris, Northcott, Keren, Nyland, Kerry, Oliver, Catherine, Oliver, Elizabeth, Oliver, Jennifer, Owen, Diana, Paterson, Jemma, Pearce, Lauren, Pegler, Suzannah, Price, Zoe, Pynsent, William B., Ramos, Lidia, Rampling, Tommy, Rea, David, Regan, Karen, Riaz, Tawassal, Ricamara, Marivic, Rice, Danielle, Rich, Melody, Roots, Marianne, Ryan, Kathryn Ann, Sakagami, Yukari, Salem, Ahmed, Salter-Hewitt, Jade, Samuels, Michelle, Santoloce, Silvia, Seaman, Siwan, Seneviratne, Michael, Shankland, Sara, Silva, Louise, Smart, Katie, Smith, Rachel M., Smith, Joyce, Stringer, Rebecca, Talbot, Helen, Tarling, Teresa, Taylor, Sarah Louise, Thomas, Amy, Tilzey, Grace, Townley, Gina, Trembath, Lisa, Turkentine, Kate, Turner, Kelly, Tyler, Jenny, Ugoji, Jacinta, Wale, Katharine, Walker-Smith, Terrie, Walton, Maggie, Warnes, Barbara, Whittley, Sarah, Williams, Jennie, Williams, Gail, Williamson, Kevin, Yim, Yee Ting Nicole, Youlden, Nicola, Lazarus, Rajeka, Baos, Sarah, Cappel-Porter, Heike, Carson-Stevens, Andrew, Clout, Madeleine, Culliford, Lucy, Emmett, Stevan R, Garstang, Jonathan, Gbadamoshi, Lukuman, Hallis, Bassam, Harris, Rosie A, Hutton, David, Jacobsen, Nick, Joyce, Katherine, Kaminski, Rachel, Libri, Vincenzo, Middleditch, Alex, McCullagh, Liz, Moran, Ed, Phillipson, Adrian, Price, Elizabeth, Ryan, John, Thirard, Russell, Todd, Rachel, Snape, Matthew D, Tucker, David, Williams, Rachel Lauren, Nguyen-Van-Tam, Jonathan S, Finn, Adam, and Rogers, Chris A

Published
2021
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13. Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: A protocol for a randomised controlled study (ProMPT2).

Author

Heys, Rachael, Angelini, Gianni D, Joyce, Katherine, Smartt, Helena, Culliford, Lucy, Maishman, Rachel, de Jesus, Samantha E, Emanueli, Costanza, Suleiman, M-Saadeh, Punjabi, Prakash, Rogers, Chris A, and Gibbison, Ben

Subjects
CARDIOPULMONARY bypass, TREATMENT effectiveness, RANDOMIZED controlled trials, PROPOFOL, DRUG efficacy, CARDIAC surgery, BIOMARKERS, EVALUATION
Abstract

Introduction: Cardiac surgery with cardiopulmonary bypass and cardioplegic arrest is known to be responsible for ischaemia and reperfusion organ injury. In a previous study, ProMPT, in patients undergoing coronary artery bypass or aortic valve surgery we demonstrated improved cardiac protection when supplementing the cardioplegia solution with propofol (6 mcg/ml). The aim of the ProMPT2 study is to determine whether higher levels of propofol added to the cardioplegia could result in increased cardiac protection. Methods and Analysis: The ProMPT2 study is a multi-centre, parallel, three-group, randomised controlled trial in adults undergoing non-emergency isolated coronary artery bypass graft surgery with cardiopulmonary bypass. A total of 240 patients will be randomised in a 1:1:1 ratio to receive either cardioplegia supplementation with high dose of propofol (12 mcg/ml), low dose of propofol (6 mcg/ml) or placebo (saline). The primary outcome is myocardial injury, assessed by serial measurements of myocardial troponin T up to 48 hours after surgery. Secondary outcomes include biomarkers of renal function (creatinine) and metabolism (lactate). Ethics and Dissemination: The trial received research ethics approval from South Central – Berkshire B Research Ethics Committee and Medicines and Healthcare products Regulatory Agency in September 2018. Any findings will be shared though peer-reviewed publications and presented at international and national meetings. Participants will be informed of results through patient organisations and newsletters. Trial Registration: ISRCTN15255199. Registered in March 2019. [ABSTRACT FROM AUTHOR]

Published
2024
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14. PET-CT-guidedversusCT-guided biopsy in suspected malignant pleural thickening: a randomised trial

Author

de Fonseka, Duneesha, primary, Arnold, David T., additional, Smartt, Helena J.M., additional, Culliford, Lucy, additional, Stadon, Louise, additional, Tucker, Emma, additional, Morley, Anna, additional, Zahan-Evans, Natalie, additional, Bibby, Anna C., additional, Lynch, Geraldine, additional, Mishra, Eleanor, additional, Khan, Shahul, additional, Haris, Mohammed, additional, Steer, Henry, additional, Lewis, Leon, additional, Ionescu, Alina, additional, Harvey, John, additional, Blyth, Kevin, additional, Rahman, Najib M., additional, Edey, Anthony E., additional, Rogers, Chris A., additional, and Maskell, Nick A., additional

Published
2023
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15. Acceptability of Home Monitoring for Neovascular Age-Related Macular Degeneration Reactivation: A Qualitative Study.

Author

O'CONNOR, Sean, TREANOR, Charlene, WARD, Elizabeth, WICKENS, Robin, O'CONNELL, Abby, CULLIFORD, Lucy, ROGERS, Chris, GIDMAN, Eleanor, PETO, Tunde, KNOX, Paul, BURTON, Benjamin, LOTERY, Andrew, SIVAPRASAD, Sobha, REEVES, Barnaby, HOGG, Ruth, and DONNELLY, Michael

Abstract

This study formed part of a diagnostic test accuracy study to quantify the ability of three index home monitoring (HM) tests (one paper-based and two digital tests) to identify reactivation in Neovascular age-related macular degeneration (nAMD). The aim of the study was to investigate views about acceptability and explore adherence to weekly HM. Semi-structured interviews were held with 98 patients, family members, and healthcare professionals. A thematic approach was used which was informed by theories of technology acceptance. Various factors influenced acceptability including a patient's understanding about the purpose of monitoring. Training and ongoing support were regarded as essential for overcoming unfamiliarity with digital technology. Findings have implications for implementation of digital HM in the care of older people with nAMD and other long-term conditions. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)

Author

Lazarus, Rajeka, Harris, Rosie, Thirard, Russell, Baos, Sarah, Culliford, Lucy, Todd, Rachel, Hallis, Bassam, Charlton, Sue, Finn, Adam, Snape, Matthew D., and Rogers, Chris A.

Published
2024
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17. PREHABILITATION FOR FRAIL PATIENTS UNDERGOING TOTAL HIP OR KNEE ARTHROPLASTY: PROTOCOL FOR THE JOINT PREP FEASIBILITY RANDOMIZED CONTROLLED TRIAL

Author

Khalid, Tanzeela, primary, Ben-Shlomo, Yoav, additional, Bertram, Wendy, additional, Culliford, Lucy, additional, England, Clare, additional, Henderson, Emily, additional, Jameson, Catherine, additional, Jepson, Marcus, additional, Palmer, Shea, additional, Whitehouse, Michael, additional, and Wylde, Vikki, additional

Published
2023
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20. Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)

Author

Heys, Rachael, primary, Walker-Smith, Terrie, additional, Evans, Rebecca, additional, Caputo, Massimo, additional, Culliford, Lucy, additional, Reeves, Barnaby, additional, Rogers, Chris, additional, Turner, Mark, additional, Hamilton, Mark, additional, Sheehan, Karen, additional, Viola, Nicola, additional, Stoica, Serban, additional, Wright, Kim, additional, Angelini, Gianni, additional, and Parry, Andrew, additional

Published
2023
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21. Efficacy and safety of carbon dioxide insufflation for brain protection for patients undergoing planned left-sided open heart valve surgery: protocol for a multicentre, placebo-controlled, blinded, randomised controlled trial (the CO2 Study)

Author

Todd, Rachel, primary, Rogers, Chris A, additional, Pufulete, Maria, additional, Culliford, Lucy, additional, Pretorius, Pieter, additional, Voets, Natalie, additional, Akowuah, Enoch, additional, Sayeed, Rana, additional, Lazaroo, Michelle, additional, Kaur, Surinder, additional, Angelini, Gianni D, additional, and Gibbison, Ben, additional

Published
2023
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23. Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

Author

Parker, Adwoa, Arundel, Catherine, Clark, Laura, Coleman, Elizabeth, Doherty, Laura, Hewitt, Catherine Elizabeth, Beard, David, Bower, Peter, Cooper, Cindy, Culliford, Lucy, Devane, Declan, Emsley, Richard, Eldridge, Sandra, Galvin, Sandra, Gillies, Katie, Montgomery, Alan, Sutton, Christopher J., Treweek, Shaun, and Torgerson, David J.

Published
2024
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24. Prehabilitation for frail patients undergoing total hip or knee replacement: protocol for the Joint PREP feasibility randomised controlled trial

Author

Khalid, Tanzeela, primary, Ben-Shlomo, Yoav, additional, Bertram, Wendy, additional, Culliford, Lucy, additional, England, Clare, additional, Henderson, Emily, additional, Jameson, Catherine, additional, Jepson, Marcus, additional, Palmer, Shea, additional, Whitehouse, Michael, additional, and Wylde, Vikki, additional

Published
2023
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26. Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: A protocol for a randomised controlled study (ProMPT2)

Author

Heys, Rachael, primary, Angelini, Gianni D, additional, Joyce, Katherine, additional, Smartt, Helena, additional, Culliford, Lucy, additional, Maishman, Rachel, additional, de Jesus, Samantha E, additional, Emanueli, Costanza, additional, Suleiman, M-Saadeh, additional, Punjabi, Prakash, additional, Rogers, Chris A, additional, and Gibbison, Ben, additional

Published
2023
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27. PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Author

Doherty, Laura, primary, Parker, Adwoa, additional, Arundel, Catherine, additional, Clark, Laura, additional, Coleman, Elizabeth, additional, Hewitt, Catherine, additional, Beard, David, additional, Bower, Peter, additional, Brocklehurst, Paul, additional, Cooper, Cindy, additional, Culliford, Lucy, additional, Devane, Declan, additional, Emsley, Richard, additional, Eldridge, Sandra, additional, Galvin, Sandra, additional, Gillies, Katie, additional, Montgomery, Alan, additional, Sutton, Chris, additional, Treweek, Shaun, additional, and Torgerson, David, additional

Published
2022
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29. A cohort study of circulating progenitor cells after ST-segment elevation and non-ST segment elevation myocardial infarction in non-diabetic and diabetic patients

Author

Baumbach, Andreas, primary, Cui, Yu-Xin, additional, Evans, Rebecca N., additional, Culliford, Lucy, additional, Johnson, Tom, additional, Rogers, Chris A., additional, Reeves, Barnaby C., additional, Bucciarelli-Ducci, Chiara, additional, Harris, Jessica, additional, Hamilton, Mark, additional, and Madeddu, Paolo, additional

Published
2022
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31. The COVID-19 Pandemic and Ophthalmic Care:A Qualitative Study of Patients with Neovascular Age-Related Macular Degeneration (nAMD)

Author

O'Connor, Seán R., Treanor, Charlene, Ward, Elizabeth, Wickens, Robin A., O'Connell, Abby, Culliford, Lucy A., Rogers, Chris A., Gidman, Eleanor A., Peto, Tunde, Knox, Paul C., Burton, Benjamin J. L., Lotery, Andrew J., Sivaprasad, Sobha, Reeves, Barnaby C., Hogg, Ruth E., Donnelly, Michael, and MONARCH Study Group

Subjects
COVID-19, patient perspective, ophthalmic care, qualitative methods, Health, Toxicology and Mutagenesis, Physical Distancing, Public Health, Environmental and Occupational Health, BTC (Bristol Trials Centre), Macular Degeneration, Macular Degeneration/epidemiology, Humans, Pandemics, Qualitative Research, COVID-19/epidemiology
Abstract

Concerns have been expressed about the relationship between reduced levels of health care utilisation and the COVID-19 pandemic. This study aimed to elicit and explore the views of patients with neovascular age-related macular degeneration (nAMD) regarding the COVID-19 pandemic and their ophthalmic care. Semi-structured telephone interviews were conducted with thirty-five patients with nAMD taking part in a larger diagnostic accuracy study of home-monitoring tests. Participants were recruited using maximum variation sampling to capture a range of key characteristics including age, gender and time since initial treatment. Transcribed interview data were analysed using a deductive and inductive thematic approach. Three themes emerged from the analysis: i. access to eye clinic care. ii. COVID-19-mitigating factors and care delivery and iii. social and personal circumstances. Participants reported anxieties about cancelled or delayed appointments, limited communication from clinic-based services about appointments, and the impact of this on their ongoing care. Despite these concerns, there was apprehension about attending appointments due to infection risk and a perception that nAMD patients are a ‘high risk’ group. Views of those who attended clinics during the study period were, however, positive, with social distancing and infection control measures providing reassurance. These findings contribute to our understanding about experiences of patients with nAMD during the COVID-19 pandemic and may have potential implications for future planning of care services in similar circumstances. Innovative approaches may be required to address issues related to access to care, including concerns about delayed or cancelled appointments.

Published
2022

33. Staff training to improve participant recruitment into surgical randomised controlled trials:a feasibility Study Within A Trial (SWAT) across four host randomised controlled trials simultaneously

Author

Parker, Adwoa, Mills, Nicola J, Rooshenas, Leila, Jepson, Marcus J, Donovan , Jenny L, Blazeby, Jane, and Culliford, Lucy A

Abstract

ObjectiveTo test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection.Study design and settingTwelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later.ResultsFour RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p = 0.002). There was no effect on recruitment rate.ConclusionIt was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.

Published
2022

34. Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously

Author

Parker, Adwoa, primary, Arundel, Catherine, additional, Mills, Nicola, additional, Rooshenas, Leila, additional, Jepson, Marcus, additional, Donovan, Jenny L, additional, Blazeby, Jane M, additional, Coleman, Elizabeth, additional, Clark, Laura, additional, Doherty, Laura, additional, Hewitt, Catherine E, additional, Partha Sarathy, Prasanna, additional, Beard, David, additional, Bower, Peter, additional, Brealey, Stephen, additional, Brocklehurst, Paul, additional, Cooper, Cindy, additional, Croft, Julie, additional, Culliford, Lucy, additional, Dias, Joseph, additional, Devane, Declan, additional, Eldridge, Sandra, additional, Emsley, Richard, additional, Galvin, Sandra, additional, Gemperle-Mannion, Elke, additional, Jayne, David G, additional, Metcalfe, Andrew J, additional, Montgomery, Alan, additional, Rangan, Amar, additional, Sutton, Christopher J, additional, Tharmanathan, Puvanendran, additional, Treweek, Shaun, additional, and Torgerson, David, additional

Published
2022
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35. The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs

Author

Clark, Laura, primary, Arundel, Catherine, additional, Coleman, Elizabeth, additional, Doherty, Laura, additional, Parker, Adwoa, additional, Hewitt, Catherine, additional, Beard, David, additional, Bower, Peter, additional, Brocklehurst, Paul, additional, Cooper, Cindy, additional, Culliford, Lucy, additional, Devane, Declan, additional, Emsley, Richard, additional, Eldridge, Sandra, additional, Galvin, Sandra, additional, Gillies, Katie, additional, Montgomery, Alan, additional, Sutton, Chris, additional, Treweek, Shaun, additional, and Torgerson, David, additional

Published
2022
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36. Supplemental Material - PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Author

Doherty, Laura, Parker, Adwoa, Arundel, Catherine, Clark, Laura, Coleman, Elizabeth, Hewitt, Catherine, Beard, David, Bower, Peter, Brocklehurst, Paul, Cooper, Cindy, Culliford, Lucy, Devane, Declan, Emsley, Richard, Eldridge, Sandra, Galvin, Sandra, Gillies, Katie, Montgomery, Alan, Sutton, Chris, Treweek, Shaun, and Torgerson, David

Subjects
160807 Sociological Methodology and Research Methods, FOS: Sociology
Abstract

Supplemental Material for PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely by Laura Doherty, Adwoa Parker, Catherine Arundel, Laura Clark, Elizabeth Coleman, Catherine Hewitt, David Beard, Peter Bower, Paul Brocklehurst, Cindy Cooper, Lucy Culliford, Declan Devane, Richard Emsley, Sandra Eldridge, Sandra Galvin, Katie Gillies, Alan Montgomery, Chris Sutton, Shaun Treweek, David Torgerson in Research Methods in Medicine & Health Sciences

Published
2022
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37. PROMoting the use of studies within a trial (PROMETHEUS): Results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely

Author

Doherty, Laura, Parker, Adwoa, Arundel, Catherine, Clark, Laura, Coleman, Elizabeth, Hewitt, Catherine, Beard, David, Bower, Peter, Brocklehurst, Paul, Cooper, Cindy, Culliford, Lucy, Devane, Declan, Emsley, Richard, Eldridge, Sandra, Galvin, Sandra, Gillies, Katie, Montgomery, Alan, Sutton, Chris, Treweek, Shaun, and Torgerson, David

Abstract

Aim PROMoting THE USE of Studies Within A Trial (PROMETHEUS) aimed to improve the evidence base for recruiting and retaining participants in Randomised Controlled Trials (RCTs) by pump-priming and facilitating the start of at least 25 Studies Within A Trial (SWATs) testing recruitment or retention interventions.Methods Ten Clinical Trials Units (CTUs) and one Primary Care Research Centre formed a network to conduct randomised SWATs of recruitment and/or retention strategies. We identified promising recruitment and retention interventions from various sources, which were reviewed by patient and public (PPI) partners to generate an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement, and report SWATs. We additionally tested the feasibility of undertaking coordinated SWATs across multiple host trials simultaneously.Results PROMETHEUS funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The SWAT cost per SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT in multiple trials (simultaneous SWAT design)and eight tested a factorial SWAT design. PROMETHEUS will add 18% and 79% more SWATs to the Cochrane systematic review of recruitment strategies and the Cochrane review of retention strategies respectively.Conclusion The PROMETHEUS programme substantially increased the evidence base for both recruitment and retention strategies within RCTs. Future research should adopt a systematic approach to identifying and targeting gaps in the evidence base and focus on translating SWAT evidence into recruitment and retention practice.

Published
2023
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38. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial

Author

Lazarus, Rajeka, primary, Baos, Sarah, additional, Cappel-Porter, Heike, additional, Carson-Stevens, Andrew, additional, Clout, Madeleine, additional, Culliford, Lucy, additional, Emmett, Stevan R, additional, Garstang, Jonathan, additional, Gbadamoshi, Lukuman, additional, Hallis, Bassam, additional, Harris, Rosie A, additional, Hutton, David, additional, Jacobsen, Nick, additional, Joyce, Katherine, additional, Kaminski, Rachel, additional, Libri, Vincenzo, additional, Middleditch, Alex, additional, McCullagh, Liz, additional, Moran, Ed, additional, Phillipson, Adrian, additional, Price, Elizabeth, additional, Ryan, John, additional, Thirard, Russell, additional, Todd, Rachel, additional, Snape, Matthew D, additional, Tucker, David, additional, Williams, Rachel Lauren, additional, Nguyen-Van-Tam, Jonathan S, additional, Finn, Adam, additional, Rogers, Chris A, additional, Adams, Kirsty, additional, Alaee, Seema, additional, Aley, Parvinder K., additional, Allum, Emma, additional, Anthony, Sally, additional, Ashton, Kate, additional, Awal, Tanya, additional, Barnett, Liz, additional, Barratt, Alison, additional, Barron, Charlotte, additional, Baum, Holly, additional, Beard, Chloe, additional, Bennett, Lorna, additional, Bird, Samuel, additional, Bishop, Sarah, additional, Bisset, Jess, additional, Bodalia, Pritesh, additional, Bowles, Jane, additional, Bowyer, Catherine, additional, Bradburn, Kirstie, additional, Bray, Jonathan J.H., additional, Bressington, Catherine, additional, Brimfield, Matthew, additional, Broad, Lauren, additional, Brown, Pauline, additional, Brydon-Hill, Ruth, additional, Burge, Sharon, additional, Carmichael, David, additional, Chohan, Gurjit, additional, Clark, Tonia, additional, Close, Adrianne, additional, Coleman, Tom, additional, Cowley, Claire, additional, Cranfield, Charlotte, additional, Cross, Eleanor, additional, D'Agostino, Alyssa, additional, D'Arcangelo, Silvia, additional, David Otter, Ashley, additional, Davies, Kate, additional, Davies, Catrin, additional, Davies, Ru, additional, Davies, Louisa, additional, Driver, Kimberley, additional, Eglinton, Charlotte, additional, Ekblad, Charlotte, additional, Eldridge, Emma, additional, Evans, Teriann, additional, Evans, Mim, additional, Evans, Isabel, additional, F Mujadidi, Yama, additional, Farrow, Amanda, additional, Faulkner, Beverley, additional, Feltham, Sally, additional, Figueirido, Susan, additional, Ford, Jamie, additional, Foxwell, David, additional, Frayling, Sharon, additional, Gardiner, Sophie, additional, Gooch, Karen E., additional, Goodwin, Jayne, additional, Halliday, Alice, additional, Hamal, Shama, additional, Harrhy, Sarah, additional, Harris, Andrew, additional, Haxton, Lesley, additional, Haynes, Matthew, additional, Hazell, Mae, additional, Hembrough, Tracey, additional, Hewson, Jacqueline, additional, Hicks, Bethany, additional, Higgins, Thomas, additional, Hill, Michelle, additional, Hills, Alex, additional, Hilton, Zoe, additional, Hitchings, Benjamin, additional, Hua, Cheryl, additional, Iftikhar, Hina, additional, Iqbal, Attya, additional, Jones, Laura, additional, Jones, Nicola, additional, Kellett Wright, Johanna, additional, Kidd, Sarah, additional, Kirby, Alison, additional, Knibbs, Lucy, additional, Lamb, Jenny, additional, Langton, Helen, additional, Leach, Rwth, additional, Lewis-Clarke, Phoebe, additional, Lloyd, Amy, additional, Maclean, Kirsty, additional, Manning, Nicola, additional, Marriott, Anthony, additional, McFadzean, Isobel Joy, additional, McLaughlin, Maeve, additional, McQueen, Alison, additional, Mills, Bianca, additional, Naik, Gurudutt, additional, Nicholls, Lisa, additional, Norman, Chris, additional, Northcott, Keren, additional, Nyland, Kerry, additional, Oliver, Catherine, additional, Oliver, Elizabeth, additional, Oliver, Jennifer, additional, Owen, Diana, additional, Paterson, Jemma, additional, Pearce, Lauren, additional, Pegler, Suzannah, additional, Price, Zoe, additional, Pynsent, William B., additional, Ramos, Lidia, additional, Rampling, Tommy, additional, Rea, David, additional, Regan, Karen, additional, Riaz, Tawassal, additional, Ricamara, Marivic, additional, Rice, Danielle, additional, Rich, Melody, additional, Roots, Marianne, additional, Ryan, Kathryn Ann, additional, Sakagami, Yukari, additional, Salem, Ahmed, additional, Salter-Hewitt, Jade, additional, Samuels, Michelle, additional, Santoloce, Silvia, additional, Seaman, Siwan, additional, Seneviratne, Michael, additional, Shankland, Sara, additional, Silva, Louise, additional, Smart, Katie, additional, Smith, Rachel M., additional, Smith, Joyce, additional, Stringer, Rebecca, additional, Talbot, Helen, additional, Tarling, Teresa, additional, Taylor, Sarah Louise, additional, Thomas, Amy, additional, Tilzey, Grace, additional, Townley, Gina, additional, Trembath, Lisa, additional, Turkentine, Kate, additional, Turner, Kelly, additional, Tyler, Jenny, additional, Ugoji, Jacinta, additional, Wale, Katharine, additional, Walker-Smith, Terrie, additional, Walton, Maggie, additional, Warnes, Barbara, additional, Whittley, Sarah, additional, Williams, Jennie, additional, Williams, Gail, additional, Williamson, Kevin, additional, Yim, Yee Ting Nicole, additional, and Youlden, Nicola, additional

Published
2021
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43. Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol

Author

Clout, Madeleine, primary, Blazeby, Jane, additional, Rogers, Chris, additional, Reeves, Barnaby, additional, Lazaroo, Michelle, additional, Avery, Kerry, additional, Blencowe, Natalie S, additional, Vohra, Ravi, additional, Jennings, Neil, additional, Hollingworth, William, additional, Thorn, Joanna, additional, Jepson, Marcus, additional, Collingwood, Jane, additional, Guthrie, Ashley, additional, Booth, Elizabeth, additional, Pathak, Samir, additional, Beckingham, Ian, additional, Culliford, Lucy, additional, Griffiths, Ewen A, additional, Albazaz, Raneem, additional, and Toogood, Giles, additional

Published
2021
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44. Comparison of alternate preparative techniques on wall thickness in coronary artery bypass grafts: The HArVeST randomized controlled trial

Author

Angelini, Gianni D, Johnson, Tom, Culliford, Lucy, Murphy, Gavin, Ashton, Kate, Harris, Tracy, Edwards, Julia, Clayton, Gemma, Kim, Yongcheol, Newby, Andrew C, Reeves, Barney C, Rogers, Chris A, and Clayton, Gemma L

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, 030204 cardiovascular system & hematology, Distension, law.invention, 03 medical and health sciences, Coronary artery bypass surgery, Hydrostatic test, 0302 clinical medicine, Randomized controlled trial, law, Adventitia, Intravascular ultrasound, medicine, Humans, Saphenous Vein, Coronary Artery Bypass, Vein, Vascular Patency, Ultrasonography, medicine.diagnostic_test, business.industry, Saphenous Vein/diagnostic imaging, Confidence interval, Surgery, medicine.anatomical_structure, 030228 respiratory system, Tissue and Organ Harvesting, Wall thickness, Cardiology and Cardiovascular Medicine, business, Artery
Abstract

BACKGROUND: The success of coronary artery bypass grafting surgery (CABG) is dependent on long-term graft patency, which is negatively related to early wall thickening. Avoiding high-pressure distension testing for leaks and preserving the surrounding pedicle of fat and adventitia during vein harvesting may reduce wall thickening.METHODS: A single-centre, factorial randomized controlled trial was carried out to compare the impact of testing for leaks under high versus low pressure and harvesting the vein with versus without the pedicle in patients undergoing CABG. The primary outcomes were graft wall thickness, as indicator of medial-intimal hyperplasia, and lumen diameter assessed using intravascular ultrasound after 12 months.RESULTS: Ninety-six eligible participants were recruited. With conventional harvest, low-pressure testing tended to yield a thinner vessel wall compared with high-pressure (mean difference [MD; low minus high] -0.059 mm, 95% confidence interval (CI) -0.12, +0.0039, p = .066). With high pressure testing, veins harvested with the pedicle fat tended to have a thinner vessel wall than those harvested conventionally (MD [pedicle minus conventional] -0.057 mm, 95% CI: -0.12, +0.0037, p = .066, test for interaction p = .07). Lumen diameter was similar across groups (harvest comparison p = .81; pressure comparison p = .24). Low-pressure testing was associated with fewer hospital admissions in the 12 months following surgery (p = .0008). Harvesting the vein with the pedicle fat was associated with more complications during the index admission (p = .0041).CONCLUSIONS: Conventional saphenous vein graft preparation with low-pressure distension and harvesting the vein with a surrounding pedicle yielded similar graft wall thickness after 12 months, but low pressure was associated with fewer adverse events.

Published
2021

45. Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously

Author

Parker, Adwoa, Arundel, Catherine, Mills, Nicola, Rooshenas, Leila, Jepson, Marcus, Donovan, Jenny L, Blazeby, Jane M, Coleman, Elizabeth, Clark, Laura, Doherty, Laura, Hewitt, Catherine E, Partha Sarathy, Prasanna, Beard, David, Bower, Peter, Brealey, Stephen, Brocklehurst, Paul, Cooper, Cindy, Croft, Julie, Culliford, Lucy, Dias, Joseph, Devane, Declan, Eldridge, Sandra, Emsley, Richard, Galvin, Sandra, Gemperle-Mannion, Elke, Jayne, David G, Metcalfe, Andrew J, Montgomery, Alan, Rangan, Amar, Sutton, Christopher J, Tharmanathan, Puvanendran, Treweek, Shaun, and Torgerson, David

Abstract

Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection.Study design and setting Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later.Results Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p= 0.002). There was no effect on recruitment rate.Conclusion It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.

Published
2023
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47. The Safety and Immunogenicity of Concomitant Administration of COVID-19 Vaccines (ChAdOx1 or BNT162b2) with Seasonal Influenza Vaccines in Adults: A Phase IV, Multicentre Randomised Controlled Trial with Blinding (ComFluCOV)

Author

Lazarus, Rajeka, primary, Baos, Sarah, additional, Cappel-Porter, Heike, additional, Carson-Stevens, Andrew, additional, Clout, Madeleine Clout, additional, Culliford, Lucy, additional, Emmett, Stevan R, additional, Garstang, Jonathan, additional, Gbadamoshi, Lukuman, additional, Hallis, Bassam, additional, Harris, Rosie A, additional, Hutton, David, additional, Jacobsen, Nick, additional, Joyce, Katherine, additional, Kaminski, Rachel, additional, Libri, Vincenzo, additional, Middleditch, Alexander, additional, McCullagh, Liz, additional, Moran, Ed, additional, Phillipson, Adrian, additional, Price, Elizabeth, additional, Ryan, John, additional, Thirard, Russell, additional, Todd, Rachel, additional, Snape, Matthew D., additional, Tucker, David, additional, Williams, Rachel, additional, Nguyen-Van-Tam, Jonathan S., additional, Finn, Adam, additional, Rogers, Chris, additional, and Group, ComfluCOV Trial, additional

Published
2021
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48. Eplerenone versus placebo for chronic central serous chorioretinopathy: the VICI RCT

Author

Lotery, Andrew, primary, Sivaprasad, Sobha, additional, O’Connell, Abby, additional, Harris, Rosie A, additional, Culliford, Lucy, additional, Cree, Angela, additional, Madhusudhan, Savita, additional, Griffiths, Helen, additional, Ellis, Lucy, additional, Chakravarthy, Usha, additional, Peto, Tunde, additional, Rogers, Chris A, additional, and Reeves, Barnaby C, additional

Published
2021
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49. Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study)

Author

Baos, Sarah, primary, Rogers, Chris A, additional, Abbadi, Reyad, additional, Alzetani, Aiman, additional, Casali, Gianluca, additional, Chauhan, Nilesh, additional, Collett, Laura, additional, Culliford, Lucy, additional, de Jesus, Samantha E, additional, Edwards, Mark, additional, Goddard, Nicholas, additional, Lamb, Jennifer, additional, McKeon, Holly, additional, Molyneux, Mat, additional, Stokes, Elizabeth A, additional, Wordsworth, Sarah, additional, Gibbison, Ben, additional, and Pufulete, Maria, additional

Published
2020
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50. Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS)

Author

Angelini, Gianni D, primary, Reeves, Barnaby C, additional, Evans, Jonathan, additional, Culliford, Lucy A, additional, Collett, Laura, additional, Rogers, Chris A, additional, Stokes, Elizabeth, additional, Anastasiadis, Kyriakos, additional, Antonitsis, Polychronis, additional, Carrel, Thierry, additional, Keller, Dorothée, additional, Liebold, Andreas, additional, Ashkanani, Fatma, additional, El-Essawi, Aschraf, additional, Breitenbach, Ingo, additional, Lloyd, Clinton, additional, Bennett, Mark, additional, Cale, Alex, additional, Mclean, Lindsay, additional, Gunaydin, Serdar, additional, Gunertem, Eren, additional, Oueida, Farouk, additional, Yassin, Ibrahim, additional, Serrick, Cyril, additional, Rao, Vivek, additional, Moscarelli, Marco, additional, Condello, Ignazio, additional, Punjabi, Prakash, additional, Rajakaruna, Cha, additional, Bone, Daniel, additional, Lansdown, William, additional, Moorjani, Narain, additional, and Dennis, Sarah, additional

Published
2020
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